An interventional study of Rilonacept and Corticosteroid in Subacromial Bursitis, sponsored by Keesler Air Force Base Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-04.
Sponsored by Keesler Air Force Base Medical Center · Not applicable, Interventional, and Treatment
To date no trials have been performed looking at whether or not intra-bursal injection of an IL-1 antagonist provides pain relief similar to that of a corticosteroid injection. The subcutaneous injection of anakinra, an IL-1 receptor antagonist, in patients with shoulder pain due to rotator cuff tendonitis and subacromial bursitis was efficacious in relieving pain but this information was presented as a case series in a letter to the editor format, so the validity of these results would require additional testing [Omoigui S, et al. 2004]. Based mainly on the data from the intra-articular administration of anakinra, there have not been any adverse trends in outcomes or safety to suggest that intra-bursal injection of rilonacept will carry an increase risk of adverse events. The purpose of this trial is to compare the improvement in pain and function of patients with clinical symptoms and signs of subacromial bursitis of rilonacept vs. corticosteroid injection (standard of care).
Background: Subacromial bursitis is an inflammatory condition which is typically triggered by altered rotator cuff mechanics. One of the mainstays of therapy is corticosteroid injection. Given the inflammatory nature of subacromial bursitis coupled with prominence of interleukin-1 (IL-1) beta on histopathologic assessment of resected subacromial bursa, targeted anti-IL-1 therapy would be an attractive alternative to corticosteroid injection.
Hypothesis: One intra-bursal injection of the IL-1 trap rilonacept (Arcalyst ®), currently FDA approved for the treatment of cryopyrin associated periodic syndrome (CAPS), is non-inferior to intra-bursal corticosteroid injection at 4 weeks post-procedure.
Methods: This study is a prospective trial lasting a total of 4 weeks. Patients with typical symptoms and signs of subacromial bursitis are randomized to either corticosteroid injection prepared in the usual fashion in clinic vs. injection of rilonacept. Prior to injection of either medication patients will complete a QuickDASH Questionnaire and provide a verbal pain score from 0 to 10. The Quick DASH Questionnaire and verbal pain score are then completed within 2 duty days of injection, 2 weeks after injection, and 4 weeks after injection by phone.
Primary Outcome: Primary outcome is improvement in QuickDASH. Secondary outcomes are improvement in the verbal pain score and monitoring for infection or other complications from rilonacept administration.
411 studies on the registry are indexed under Bursitis; 113 are open to participants now.
This study's enrollment of 33 is below the median of 45 across 371 interventional studies indexed under Bursitis.
Browse Bursitis studies →Keesler Air Force Base Medical Center is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.
Drug: Rilonacept
80 mg (2 cc of 40 mg/mL) Kenalog intra-bursal once
Drug: Corticosteroid
160 mg intra-bursal once
Also known as: Arcalyst
2 cc (40 mg/mL) triamcinolone intra-bursal once
Also known as: Triamcinolone (Kenalog)
Improvement in Shoulder Function
The QuickDASH will be used as the primary outcome to assess improvement in pain and function of patients with clinical symptoms and signs of subacromial bursitis randomized to either rilonacept vs. corticosteroid injection. The QuickDASH is an 11 question form, a short version of the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH). It ranges from 0 (no symptoms/full function) to 100 (maximal symptoms/no function). No units are specified. Cutoff scores: \< 15 = no problem, 16 - 40 = problem, but working, \> 40 = unable to work. US population mean +/- SD is 10.1 +/- 14.7.
Time frame: 4 weeks
Improvement in Pain
Secondary outcomes are improvement in pain (as assessed by patient self report, range between 0 and 10, with 0 as no pain and 10 described as the worst pain in their life).
Time frame: 4 weeks
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Any adverse event reported by the study participant during the four time points studied in the trial in either arm will be recorded.
Time frame: 4 weeks
Subject recruitment was from March 2013 to December 2013. Subjects were recruited from the Internal Medicine (IM) or IM Subspecialties Clinic at a single academic community-size hospital.
| Milestone | Triamcinolone (Kenalog) | Rilonacept |
|---|---|---|
| Started | 13 | 20 |
| Completed | 13 | 20 |
| Not completed | 0 | 0 |
The QuickDASH will be used as the primary outcome to assess improvement in pain and function of patients with clinical symptoms and signs of subacromial bursitis randomized to either rilonacept vs. corticosteroid injection. The QuickDASH is an 11 question form, a short version of the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH). It ranges from 0 (no symptoms/full function) to 100 (maximal symptoms/no function). No units are specified. Cutoff scores: \< 15 = no problem, 16 - 40 = problem, but working, \> 40 = unable to work. US population mean +/- SD is 10.1 +/- 14.7.
| units on a scale | Triamcinolone (Kenalog) | Rilonacept |
|---|---|---|
| Improvement in Shoulder Function | 15.92 ± 15.40 | 38.52 ± 25.07 |
Secondary outcomes are improvement in pain (as assessed by patient self report, range between 0 and 10, with 0 as no pain and 10 described as the worst pain in their life).
| units on a scale | Triamcinolone (Kenalog) | Rilonacept |
|---|---|---|
| Improvement in Pain | 2.27 ± 1.42 | 3.85 ± 2.74 |
Any adverse event reported by the study participant during the four time points studied in the trial in either arm will be recorded.
| participants | Triamcinolone (Kenalog) | Rilonacept |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 3 | 8 |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Triamcinolone (Kenalog) | — | 1/12 (8.3%) | 2/13 (15.4%) |
| Rilonacept | — | 1/20 (5%) | 7/20 (35%) |
| Event | Triamcinolone (Kenalog) | Rilonacept |
|---|---|---|
| HospitalizationInfections and infestations | 1/12 | 1/20 |
| Event | Triamcinolone (Kenalog) | Rilonacept |
|---|---|---|
| HeadacheNervous system disorders | 0/13 | 2/20 |
| DiarrheaGastrointestinal disorders | 0/13 | 2/20 |
| Injection Site ReactionMusculoskeletal and connective tissue disorders | 1/13 | 0/20 |
| ThrushInfections and infestations | 1/13 | 0/20 |
| Acute BronchitisInfections and infestations | 0/13 | 1/20 |
| Generalized StiffnessMusculoskeletal and connective tissue disorders | 0/13 | 1/20 |
| Hand TinglingMusculoskeletal and connective tissue disorders | 0/13 | 1/20 |
Prior to starting the trial, we anticipated having to recruit 150 subjects total (75 in each arm). At our first analysis of the data, the effect size of both the rilonacept and triamcinolone were larger than expected, and a re-calculated 'n' was 29 for an alpha of 0.05 and power of 1.0000 (effect size 1.1).
| Age, Continuous(years) | Triamcinolone (Kenalog) | Rilonacept | Total |
|---|---|---|---|
| Mean | 65.6 ± 13.7 | 64.5 ± 12.1 | 65.3 ± 12.5 |
| Age, Categorical(Participants) | Triamcinolone (Kenalog) | Rilonacept | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 12 | 18 |
| >=65 years | 7 | 8 | 15 |
| Sex: Female, Male(Participants) | Triamcinolone (Kenalog) | Rilonacept | Total |
|---|---|---|---|
| Female | 8 | 12 | 20 |
| Male | 5 | 8 | 13 |
| Race (NIH/OMB)(Participants) | Triamcinolone (Kenalog) | Rilonacept | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 1 | 0 | 1 |
| White | 11 | 19 | 30 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Triamcinolone (Kenalog) | Rilonacept | Total |
|---|---|---|---|
| United States | 13 | 20 | 33 |
| Site of subacromial injection(participants) | Triamcinolone (Kenalog) | Rilonacept | Total |
|---|---|---|---|
| Right Bursa injected | 6 | 14 | 20 |
| Left Bursa injected | 7 | 6 | 13 |
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Keesler Air Force Base Medical Center